7 Major Amendments Proposed To South Korea’s K-REACH

If you supply chemical substances into the South Korean market you should be aware of a proposal to introduce seven major amendments to K-REACH. The implementation of these changes will have a significant impact on the legislation, and will consequently affect the requirements and processes involved with supplying hazardous chemicals to the market.

K-REACH – known formally as the Act on the Registration and Evaluation of Chemicals – took effect from January 1, 2015, and alongside the Chemical Control Act (CCA) it divided Korea’s existing Toxic Chemicals Control Act (TCCA) into two separate pieces of legislation. Whilst CCA focuses on the control of hazardous substances and response to chemical accidents, K-REACH focuses on the registration and evaluation of substances, with its main purpose being to protect public health and the environment through the following provisions:

As with the EU’s REACH Regulation, K-REACH is constantly evolving, and significant amendments have been put forward for public consultation. Issued on December 28, 2016 by MoE Notice No. 2016-869, South Korea’s Ministry of Environment (MoE) is now consulting on a proposed revision to the Act.

Compared with the current version, seven major changes have been proposed:

The annual reporting system will be abolished.

This is a revision of Article 8 of K-REACH, which currently specifies that manufacturers and importers of new chemical substances, or existing chemical substances manufactured, imported or sold at one ton/year or more (unless they are a specified exemption), are required to provide an annual report to the MoE of their quantities and uses. If these new draft revisions are passed, the revised K-REACH will take effect one year after the official release. The current submission deadline for annual reporting is June 30, which means that annual reporting in 2017 will still be required.

The introduction of pre-registration for companies planning to register existing substances.

A further revision of Article 8 of K-REACH, this proposal will require all existing chemicals used in quantities of one ton/year or more to be registered. To facilitate this there will be a grace period for registration, which companies will qualify for if they ‘pre-register’ the substances. It is believed that pre-registration should start at the end of 2018, which suggests that the registration deadline for South Korea’s First Priority Existing Chemicals (PEC) List still applies. The 510 chemicals on that PEC list would therefore still have to adhere to the original registration deadline of 30th June 2018.

The system for designation of Priority Existing Chemicals (PECs) in three batches for joint registration will be abolished, deleting Article 9 of K-REACH.

In its place, a phase-in registration mechanism for around 7000 existing chemical substances (this list is currently being prepared by the MoE) which are manufactured or imported at one ton/year or above will be adopted, revising Article 10 of K-REACH. In addition to this, phase-in deadlines will be set based on a tonnage band (1-10 tons/year, 10-100 tons/year, 100-1000 tons/year and more than 1000 tons/year), mirroring the provision in EU’s REACH Regulation.

Stricter authorization for uses of designated chemicals.

This proposed amendment to Article 25 of K-REACH seeks to tighten the use of chemicals subject to authorization, where the importation or other uses of certain chemical substances is to be prohibited, unless either an authorization has been granted or a specific exemption has been made. Both a list of chemical uses subject to authorization and a list of chemical uses exempt from authorization is to be published in due course.

Communication of hazard information through the supply chain will be strengthened and broadened, revising Article 29 of K-REACH.

This amendment proposes that hazard chemical information such as name, hazard risk, and safe use information regardless of quantity, content (if contained in a mixture) and registration status shall be provided to downstream users.

CMR substances (Carcinogenic, Mutagenic or Toxic for Reproduction) and PBT substances (Persistent, Bioaccumulative and Toxic) will now be subject to product notification.

This revision of Article 32 of K-REACH expands the scope for notification of products containing hazardous substances, and aims to provide more chemical safety information to downstream users and consumers.

The introduction of penalties, newly added as Article 37 Paragraph 2 of K-REACH.

Whilst the punishments have yet to be specified, penalties have been proposed for labs which produce false hazard data (whether intentionally or not), and for manufacturers or importers of chemicals who cause damage to human health or the environment, in cases where these chemicals should have been registered. The penalties for these will be proportional to revenue.

These proposals were announced on December 28, 2016, and the public has until February 6, 2017 to submit comments. If you wish to view the notice in full and/or provide feedback, you can do so here.

Whilst some of these proposed amendments aim to ease the burden of registration, if the draft is approved it could have a significant impact on the chemicals industry, with major ramifications for companies who export chemical substances to Korea.

Contributors to this article include Dr. Eleanor Grimes, MChem (Medicinal Chemistry), PhD (Chemistry), who is part of the Chemical Regulatory Team at UL Safeware Quasar.

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